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3D Print Med. 2017;3(1):1. doi: 10.1186/s41205-016-0009-5. Epub 2017 Jan 26.

Maintaining safety and efficacy for 3D printing in medicine.

Author information

1
SOMADEN LLC, Littleton, CO USA.
2
2Department of Radiology, University of Ottawa Faculty of Medicine, 501 Smyth Road, Ottawa, ON K1H 8L6 Canada.
3
3The Ottawa Hospital Research Institute, Ottawa, ON Canada.

Abstract

Background:

The increased and accelerating utilization of 3D printing in medicine opens up questions regarding safety and efficacy in the use of medical models. The authors recognize an important shift towards point-of-care manufacturing for medical models in a hospital environment. This change, and the role of the radiologist as a central facilitator of these services, opens discussion about topics ranging from clinical uses to patient safety to regulatory implications.

Results:

This project first defines three groups of patients for whom 3D printing positively impacts patient care. The steps needed for each group are described.

Conclusions:

We provide our opinions regarding the regulatory role that we feel is most appropriate, balancing safety and efficacy with the autonomy of individuals in the field to make the greatest positive impact on healthcare.

KEYWORDS:

3D printing; Additive manufacturing; Anatomical model; Medical devices; Medical model; Modified anatomical model; Radiology; Regulatory; Virtual surgical planning

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